Pediatric News - Benadryl found ineffective as infant sleep aid
Diphenhydramine, widely used by parents and endorsed by physicians to sedate babies into sleep, was found to be ineffective in the first randomized clinical trial to evaluate the drug in children under age 2.
Pharmacologic sedation is used “with surprising frequency by parents and often recommended by physicians” for babies who are judged to be problem sleepers. Antihistamines are the most widely studied of these sedatives in children, and diphenhydramine (Benadryl) is the most commonly used antihistamine. One survey of over 600 U.S. pediatricians found that 49% had recommended antihistamines as a sleep aid for children aged 0-2 years in the preceding 6 months (Pediatrics 2003;111:e628-35).
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In an multicenter investigation dubbed the Trial of Infant Response to Diphenhydramine, or the TIRED study, Dr. Dan Merenstein and his associates assessed 44 babies aged 615 months who slept in their own cribs; had difficulty falling asleep; and awoke two or more times per night, needing parental assistance to fall back to sleep. They hypothesized that babies treated for 1 week with diphenhydramine would be more likely to fall asleep without their parents and to put themselves back to sleep when they awakened during the night, compared with babies treated with placebo.
The investigators further hypothesized that during treatment, babies who received diphenhydramine would soon associate their cribs with sleep, and that this effect would carry over after treatment ended. They predicted the treated babies would demonstrate better sleeping habits at 2- and a-week follow-up than those who had received placebo (Arch. Ped. Adolesc. Med. 2006;160:707-12).
After a 1-week run-in period, half the babies were randomly assigned to receive the most commonly recommended dose of diphenhydramine (1 mg/kg) 30 minutes before bedtime every day for 1 week, and the other half to receive a placebo of purified water colored and flavored to match the drug. Parents tracked the babies’ sleep habits in a daily diary, and also rated their own happiness with their babies’ sleep. Clinicians assessed outcomes at 2, 4, and 6 weeks after enrollment.
All of the researchers’ hypotheses proved to be incorrect. The study was halted before full enrollment was completed because an interim analysis showed that diphenhydramine was ineffective.
Immediately after treatment ended, there was no significant difference in sleep improvement (number of nighttime awakenings and length of time before falling asleep) between the two groups. Only three babies in the placebo group (14%) and one in the active treatment group (5%) showed improvement.
However, by final follow-up, a small but statistically significant improvement was noted in babies who received the placebo. Five babies in the placebo group (23%) showed sleep improvement, compared with one (5%) baby in the active treatment group.
The parents’ reports of their happiness with their babies’ sleep throughout the study “were nearly identical for the two groups,” reported Dr. Merenstein of Johns Hopkins University, Baltimore, and his associates. “Many in the medical and lay community accept diphenhydramine as effective treatment for sleep problems. Unfortunately, this attitude is based on anecdote and studies of adult physiological interactions.
“The TIRED study results demonstrated that at the most commonly used dose, diphenhydramine may play no role in treating infant sleep problems,” Dr. Merenstein and his associates said.
Their findings also highlight the need for “rigorous studies of common primary care interventions” in children, as well as studies of sleep in healthy children. “Because of a lack of evidence, parents and physicians often are forced to make important decisions on the basis of anecdotal experiences,” the investigators noted.
BY MARY ANN MOON
Contributing Writer
COPYRIGHT 2006 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning
